Ignite Creation Date:
2025-12-25 @ 3:43 AM
Ignite Modification Date:
2025-12-26 @ 2:29 AM
Study NCT ID:
NCT05368402
Status:
TERMINATED
Last Update Posted:
2025-02-03
First Post:
2022-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Clinical Trial on Ladarixin Adjunctive Therapy to Improve Glycemic Control in Type 1 Diabetes.
Sponsor:
Dompé Farmaceutici S.p.A
Organization:
Study Overview
Official Title:
Randomized, Placebo-controlled, Double-blinded, 2-parallel Arm, Clinical Trial Evaluating Ladarixin 400 mg Bid as Adjunctive Therapy to Improve Glycemic Control in Overweight Insulin-resistant Patients With Type 1 Diabetes.
Status:
TERMINATED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low recruitment rate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONSERVA
Brief Summary:
Primary objective
\- To determine whether oral ladarixin versus placebo adjunctive therapy improves glycemic control in overweight, insulin resistant (IR) adult subjects with type 1 diabetes (T1D).
Secondary objectives
* To ascertain the effect of ladarixin on glycemic variability as per CGM derived parameters.
* To determine the safety of oral ladarixin versus placebo adjunctive therapy in overweight, IR adult subjects with T1D.
\- To determine whether oral ladarixin versus placebo adjunctive therapy improves glycemic control in overweight, insulin resistant (IR) adult subjects with type 1 diabetes (T1D).
Secondary objectives
* To ascertain the effect of ladarixin on glycemic variability as per CGM derived parameters.
* To determine the safety of oral ladarixin versus placebo adjunctive therapy in overweight, IR adult subjects with T1D.
Detailed Description:
This study is a randomized, placebo-controlled, double-blinded, 2- parallel arm, phase II trial.
The planned number of patients to be enrolled was 86, across all genders, 21-65 years, inclusive, with established insulin-requiring T1D and IR, to be assigned (1:1) to receive either oral ladarixin 400 mg b.i.d. for 7 cycles (26 weeks) of 14 days on/14 days off (treatment group) or matched placebo (control group).
The planned duration of treatment was 7 cycles of 14 days with an interval of 14 days off (no IMP), for 26 weeks and a for total of 5 study visits.
Actually, only 24 patients were screened, 3 enrolled and 2 were randomized. The study was terminated early due to low recruitment rates; 2 patients completed the study, and therefore only their safety data are relevant to this study report.
No efficacy evaluation was conducted due to small numbers and early study termination. As a result, no conclusions can be made about the effectiveness of the treatment.
Only safety evaluations were conducted: no missing data on safety variables for the 2 randomized participants. At study termination, no TEAEs, ADRs, TESAEs, serious or severe ADRs had occurred, and therefore the safety profile of ladarixin had not changed.
The planned number of patients to be enrolled was 86, across all genders, 21-65 years, inclusive, with established insulin-requiring T1D and IR, to be assigned (1:1) to receive either oral ladarixin 400 mg b.i.d. for 7 cycles (26 weeks) of 14 days on/14 days off (treatment group) or matched placebo (control group).
The planned duration of treatment was 7 cycles of 14 days with an interval of 14 days off (no IMP), for 26 weeks and a for total of 5 study visits.
Actually, only 24 patients were screened, 3 enrolled and 2 were randomized. The study was terminated early due to low recruitment rates; 2 patients completed the study, and therefore only their safety data are relevant to this study report.
No efficacy evaluation was conducted due to small numbers and early study termination. As a result, no conclusions can be made about the effectiveness of the treatment.
Only safety evaluations were conducted: no missing data on safety variables for the 2 randomized participants. At study termination, no TEAEs, ADRs, TESAEs, serious or severe ADRs had occurred, and therefore the safety profile of ladarixin had not changed.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2022-000743-68 | EUDRACT_NUMBER | None | View |